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Sunday, June 23, 2024

Point taken: Getting that mindset- Johnston County biotechnology manufacturing

On the east side of Clayton, in Johnston County, are two large biotechnology manufacturing plants, one operated by Denmark-based Novo Nordisk and the other by Grifols, headquartered in Spain. Near these two plants is the two-story building Workforce Development Center, run by Johnston Community College.

The companies have expanded greatly here in the past decade, and one reason is the workforce center. “In economic development, there’s about four things you gotta have,” says Tony Copeland, a former North Carolina commerce secretary. “No. 1 is employees.”

Everyone talks about the workforce. We don’t have enough workers. We don’t have enough workers with the right skills. Well, I think they have hit on something in Clayton with the workforce center. 

There are about 3,400 workers at Novo and Grifols in Clayton. The annual payroll for pharmaceutical and medicine manufacturing in Johnston County is around $268 million, about 11% of the state’s total, and No. 2 behind Durham County, which has Research Triangle Park. Three decades ago, Johnston Co. industry was mainly textiles and tobacco. Now it is one of the state’s leading life sciences manufacturing hubs. Johnston County along with the Eastern North Carolina counties of Edgecombe, Nash, Pitt and Wilson — that form the BioPharma Crescent.

When Novo Nordisk announced a major expansion in 2015, it said the jobs would pay more than $68,400, on average. The Johnston Co. average was $34,400.

HOW THEY GOT HERE

Chad Henry

Novo Nordisk makes diabetes and obesity products here and came to Clayton in 1991. It acquired a plant that was abandoned by another company. “When we bought it, it was just a shell with a dirt floor,” says Chad Henry, general manager of product supply, quality and IT for Novo in the U.S.

Novo dominated the European insulin market. It was building a 100-employee plant in Clayton to challenge Eli Lilly in the U.S. The plant would get ingredients shipped from Denmark, process them, and then fill vials and cartridges. Drug plants are highly regulated and starting a new one is a long process. It took until 1996 to get the FDA approvals. 

Across the railroad tracks from Novo’s building was a small plant that would eventually grow into the Grifols complex. In the early 1970s, it was built by Cutter Laboratories, a California company that extracted substances from donated blood plasma that could be turned into medicine. Cutter was attracted by a labor force of folks struggling to make a living on small farms who wanted to stay in rural Johnston, not yet a booming Raleigh suburb. Cutter saw hard workers who could be trained by the new Johnston Technical Institute.

SNAKES, SQUIRRELS AND A WORKFORCE PLAN

Over the years, both businesses expanded. Cutter was acquired by Bayer,  then by Talecris and in 2011 by Grifols, the same blood plasma fractionation business. Novo Nordisk remained Novo Nordisk.

Johnston County’s Workforce Development Center.

 More than 20 years ago, the companies began experiencing problems with an unreliable power grid. Every so often, a snake would get into a substation and cause outages. “That happened quite a bit because it was also a squirrel story, and it was a bird story,” recalls Henry, an N.C. State graduate who started at Novo in 2001 as a night-shift packaging supervisor.

A meeting with county, state and power company officials led to assurances that the problem would be solved. And then a legislator asked company representatives, “Is there anything else you need?” recalls Chris Johnson, the county’s economic development director.

“How about some help training a workforce?” the expansion-minded companies asked.

The technical institute, which had become Johnston Community College, agreed to build an adjacent training center. It would provide specific programs with training needed for work at Novo or Grifols, or any other life sciences plant, including how to fill vials, clean equipment and keep records. Instructors would also teach about fermentation, quality standards, and the like. It would also offer customized training.  

Johnston’s lawmakers got legislation through the 2003 session to create a research training zone mostly around the two plants. The special tax zone now raises around
$1.1 million annually to support the new workforce center.

Novo donated the land. The $4.4 million, 30,000-square foot building was funded with a USDA loan, around $750,000 from the companies and nearly $400,000 from the Rocky Mount-based Golden LEAF Foundation.  

The workforce center opened in 2005 with three science labs, two computer labs, and seven classrooms. It was called the first of its kind in the state and a model of collaboration.  Johnston County was on the rise, said former state Sen. Fred Smith, a developer who is now on the county commission. The county would attract more jobs because of the center, Smith said. He was right. 

A $2 BILLION PROJECT

In 2015, a decade after the workforce center opened, and thousands had been trained, Novo Nordisk announced it would open a second plant in Clayton, across Powhatan Road, doubling its payroll. Its research and development labs were developing a tablet to treat Type 2 diabetes, which would be preferable to injections. The company needed new capacity to manufacture active pharmaceutical ingredients, and a lot of it, especially with a Novo tablet plant to come in Durham. 

Grifols North Fractionation Facility (top); Novo Nordisk Injectable Finished Products (IFP) facility (bottom)

State and local incentives helped Clayton win the $2 billion project, but incentives don’t run a factory. Novo needed a bigger workforce, and one that could use things like DeltaV, an automation operating system used to run a phenomenally complicated set of valves, pipes and tanks to be installed in the new plant. That’s not software you can train folks on during production. The Workforce Development Center purchased DeltaV software and installed it on its computers. Trainees then learned by watching a scale model of the kinds of equipment that it runs.

“So we could take our new employees that had no experience with DeltaV, the Workforce Development Center would train them long before we actually had DeltaV set up in API,” says Henry. “Because we can’t have folks training live on live product.”

In tandem with the new plant, the workforce center got a $1.3 million upgrade in 2018 to help support the new processes.  

“The Workforce Development Center, it’s also a main driver in decision-making of where to expand for our company,” says Henry.  “Essentially, we’re investing to be able to get something back. And people all over the country are just fascinated by it.” 

Both companies have land for expansion, around 104 acres in Novo’s case. Grifols bought 467 acres in 2018. It plans a 10 million liter-a-year plasma processing plant which will employ another 300 employees. 

Grifols’ Clayton operations are the company’s largest manufacturing site, helping make the company the third-largest global manufacturer of plasma-derived medicines. In 2010, the site had a fractionation capacity of less than 2.5 million liters of plasma a year. Today, it has 9 million, and that will grow to 12 million liters later this year. Grifols also has more than 400 employees at offices in RTP.  

A PLANT WITH CLASSROOMS

I took a tour of the center. From the outside, it appears to be a typical academic building. Inside, it looks like a biopharma plant with classrooms.  

 Students can earn associate degrees, but the core of the center is its BioWork certificate program, which gets folks ready to turn left down Powhatan Road and go to Grifols or turn right and go to Novo. 

Melissa Robbins is head of the college’s biotechnology department. The Johnston County native says the demand is great for trained workers with BioWorks certificates. “It’s one semester and someone can start their career immediately,” she says. “They do interviews in the classroom. We’ve actually had to say, ‘Can you wait until they’re finished?’” 

While touring Grifols, I got the perspective of the center’s importance from Doug Burns, a 23-year plant employee who has been head of the site for four years. He came to Clayton as a researcher after earning his doctorate at the University of Delaware. 

 “We’re so [standard-operating procedure]-driven. Everything has to be done by procedure. A lot of it’s just getting that mindset. What does it mean to be clean? How can it go wrong if we don’t follow the procedure as it’s written?” 

A new employee “can advance so much faster when they’ve gone through that [BioWork] training in advance,” he says.

“Because you know what pH means. You know how to clean a vessel. You know how to fill out a batch record. And if you’ve had exposure to DeltaV, and you know what that looks like, it doesn’t mean you can run a process because we’ve got to teach you how to run a process. But you know the basics of how to navigate the software, and Grifols can train you from there.”

A MINDSET

“Getting that mindset,” is an expression that you hear repeatedly from folks around the industry, from RTP to the Biomanufacturing Training and Education Center at N.C. State, where Henry is on the board, to the BioPharma Crescent. New employees have to learn that “clean” in drug manufacturing is unlike anything else they have seen. Everything is documented, because if it isn’t written down, it didn’t happen. Folks have to learn the difference between proper record-keeping and sloppy record-keeping. 

Employees on the manufacturing floor at Novo Nordisk’s API faciliity and training at the Johnston Community College’s Workforce Development Center.

“Every batch that we make generates a stack of paper,” says Burns. “Every one of those papers has to be reviewed by quality to make sure that it’s right. They look for stray marks, miscalculations. Documentation is key.”

I talked to Bill Bullock, senior vice president at the NC Biotechnology Center, about the training operation. “The Workforce Development Center,” he says “is kind of best practice on how to do this.”

“When other communities are thinking about the possibility of building out some kind of workforce programming or center, everybody just goes there, because it’s just way ahead of its time. “

As Burns told me: “I’ve had colleagues from our plants in Los Angeles and Spain come here, and they’re incredibly envious. They have nothing like this. And they’re astounded that we have it. Because there’s something very beautiful about being able to train people on aseptic techniques and gowning – all those things whereyou worry about maintaining a clean environment – outside of that clean environment.” Each year, nearly a couple hundred new Grifols hires are likely to go through the workforce center, and as many
as 300 existing employees go for continuing education.

THE PICTURES

Over at Novo, Henry took me down a long corridor in the old plant to show me a cluster of pictures on the wall. It helped me understand why Grifols and Novo are so committed to the workforce center.

“These are our employees. These are our family members. All these people take our medicine. All these people either work here or they’re family members for what we do. We’re not making car seats. We’re making medicine to keep people alive. It has to be right the first time. You have to have a particular mindset. You
have to think a certain way.”

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